Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 8 of 580 for:    reduced glutathione

The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise (DIMITOS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02948673
Recruitment Status : Completed
First Posted : October 28, 2016
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Steen Larsen, University of Copenhagen

Brief Summary:

Objectives: The research focus of the study is the production of reactive oxygen species (ROS) in patients with type 2 diabetes (T2D) in response to glutathione (GSH) supplementation and in response to acute exercise.

Oxidative stress is suggested as a possible causative factor in the pathophysiology of skeletal muscle insulin resistance. GSH is the most abundant endogenous antioxidant in the cell and thus, a crucial protector against oxidative stress and insulin resistance. It has been found that patients with T2D have a decreased level of GSH in plasma and that 1 h GSH infusion improves skeletal muscle glucose uptake by ~25% and the redox environment in patients with T2D. Therefore, we want to investigate the effect of 3 months of GSH supplementation on skeletal muscle insulin sensitivity and mitochondrial ROS production in patients with T2D and healthy controls.

Hypothesis: Oral GSH supplementation will improve skeletal muscle insulin sensitivity in patients with T2D and this effect will be linked to a reduced mitochondrial ROS production in the skeletal muscle.

In contrast to the link between oxidative stress and insulin resistance, ROS produced in response to exercise is an important physiological stimulus as it is suggested to play a key role in the beneficial mitochondrial biogenesis observed in response to training. It has been reported that some patients with T2D have a diminished mitochondrial biogenesis in response to training, but the reason for this defect is not known. We want to investigate the link between exercise-stimulated ROS production and the mitochondrial biogenesis response in patients with T2D and healthy controls in response to acute exercise at two different intensities.

Hypothesis: Considering the pathological condition of T2D skeletal muscle (i.e. high chronic ROS level), we speculate that a lower exercise intensity, leading to a lower exercise-stimulated ROS production is a more optimal stimulus (i.e. not to high) for mitochondrial biogenesis in patients with T2D.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Oxidative Stress Mitochondrial Reactive Oxygen Species Production Dietary Supplement: Glutathione Other: Placebo Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Production of Reactive Oxygen Species in Response to Glutathione Supplementation and Acute Exercise in Patients With Type 2 Diabetes
Study Start Date : May 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Placebo Comparator: Control
4 placebo tablets/day (2 in the morning and 2 in the evening)
Other: Placebo
4 oral placebo tablets for 4 weeks

Active Comparator: Glutathione
4 oral GSH tablets/day (2 in the morning and 2 in the evening)
Dietary Supplement: Glutathione
4 oral GSH tablets/day (1000mg/day) for 4 weeks
Other Name: Setria Glutathion




Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: 12 weeks ]
    Difference in insulin sensitivity (measured as glucose infusion rate during a hyperinsulinaemic euglycaemic clamp) between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo.


Secondary Outcome Measures :
  1. Mitochondrial reactive oxygen species production [ Time Frame: 12 weeks ]
    Difference in the mitochondrial reactive oxygen species production between patients with type 2 diabetes receiving glutathione supplementation and patients with type 2 diabetes receiving placebo.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For patients with type 2 diabetes:

  • Male
  • 30-50 years
  • BMI: 28-35
  • ECG with no evidence of heart disease
  • HbA1c > 6.5% (48mmol/mol)

For control subjects:

  • Male
  • 30-50 years
  • BMI: 28-35
  • ECG with no evidence of Heart disease

Exclusion Criteria:

For patients with type 2 diabetes::

  • Insulin treatment
  • Antioxidant supplementation or other dietary supplements
  • Cholesterol lowering medicine

For control subjects:

  • Antioxidant supplementation or other dietary supplements
  • Cholesterol lowering medicine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02948673


Locations
Layout table for location information
Denmark
Xlab, Department of Biomedical Sciences, Faculty Of Health Sciences, University of Copenhagen
Copenhagen, Nørrebro, Denmark, 2200
Sponsors and Collaborators
University of Copenhagen
Investigators
Layout table for investigator information
Principal Investigator: Steen Larsen, Ass. prof. University of Copenhagen

Publications:

Layout table for additonal information
Responsible Party: Steen Larsen, Assistant Professor, DMSci., University of Copenhagen
ClinicalTrials.gov Identifier: NCT02948673     History of Changes
Other Study ID Numbers: DIMITOS
First Posted: October 28, 2016    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Steen Larsen, University of Copenhagen:
type 2 diabetes
mitochondrial reactive oxygen species production
oxidative stress
antioxidant treatment
glutathione supplementation

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases